VISAO® 3334800 (UDI 00643169882690)Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00643169882690), received between Jun 10, 2020 and Sep 11, 2026 — classified as 55 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (43 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Vibration

  It was reported that during pre-op, The doctor installed the bur and performed a test. During operation, the motor produced an abnormal noise, the bur was wobbling. The doctor tried reinstalling the bur, but the issue persisted. Therefore, the doctor replaced the handpiece with a new one to complete the surgery. The same bur worked well with another handpiece. When other bur was tried with this handpiece, bur wobbled. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728046 ↗
• MalfunctionJul 18, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540360 ↗
• MalfunctionMay 29, 2025Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT DURING THE USE THE DEVICE HEATS UP AFTER USING IT FOR MORE THAN A MINUTE AND NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107586 ↗
• MalfunctionMay 26, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE OP, THE DOCTOR INSTALLED THE HANDPIECE INTO THE IPC FOR TESTING AND FOUND THAT THE MOTOR OVERHEATED AFTER OPERATING FOR LESS THAN ONE MINUTE. THE DOCTOR TRIED TO TEST AGAIN BUT STILL OVERHEATED. FINALLY, THE DOCTOR CHANGED A HANDPIECE TO PROCEED WITH THE SURGICAL PROCEDURE. DEVICE BEING RUN AT A SPEED OF 80000 RPM AND IN FORWARD MODE AND IRRIGATION BEING USED. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083088 ↗
• MalfunctionMay 5, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-OP, BUR WOBBLES IN THE VISAO DRILL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958721 ↗
• MalfunctionMar 10, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE THE VISAO HANDPIECE GETS WARM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556833 ↗
• MalfunctionFeb 12, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING SETUP, THE BUR WOBBLES. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363731 ↗
• MalfunctionFeb 10, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, THE VISAO DILL BUR WOBBLES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341934 ↗
• MalfunctionFeb 7, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, THE VISAO DRILL HANDPIECE HAD TOOL WOBBLING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332832 ↗
• MalfunctionFeb 7, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO PROCEDURE THE BUR WOBBLES IN VISAO DRILL HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332458 ↗
• MalfunctionJan 16, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING INTRA-OP, THE BUR TIP WOBBLES IN VISAO HANDPIECE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21166100 ↗
• MalfunctionJan 6, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA-OP, THE VISAO DRILL HAD EXCESSIVE HEAT WHEN USED FOR LESS THAN A MINUTE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076757 ↗
• MalfunctionDec 6, 2024Vibration; Vibration

  IT WAS REPORTED THAT BEFORE OPERATION THE BUR WOBBLES IN INDIGO. THE BUR WAS TESTED IN ANOTHER VISAO AND IT IS WORKING FINE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861456 ↗
• MalfunctionNov 20, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT BEFORE OPERATION, DEVICE HAD OVERHEATING ISSUE. NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20731464 ↗
• MalfunctionOct 25, 2024Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT POST OP, THE VISAO DRILL WAS NOT TURNING AND HAD EXCESSIVE HEAT WHICH WAS NOTICED IN LESS THAN A MINUTE. DEVICE WAS RUNNING IN DEFAULT MODE WITH FORWARD ROTATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531223 ↗
• MalfunctionOct 21, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT POST-OP, THE VISAO DRILL WAS HEATING EXCESSIVELY IN ABOUT ONE MINUTE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490479 ↗
• MalfunctionJul 8, 2024Vibration; Vibration

  IT WAS REPORTED THAT THAT THE VISAO HANDPIECE WAS VIBRATING WHEN IN USE DURING THE DEMO. THE BLADE WAS ALSO VIBRATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687046 ↗
• MalfunctionMay 20, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL WAS PLUGGED IN AND THE IRRIGATION AND COOLING TUBING WERE PROPERLY SET UP. AFTER A MINUTE OF DRILLING, THE TOP PORTION OF THE DRILL WAS OVERHEATING. THE CLINICAL TEAM PUT THE DRILL ASIDE FOR IT TO COOL DOWN AND TRIED AGAIN AND EXPERIENCED THE SAME ISSUE. THE SURGERY COULD NOT BE COMPLETED. THE EVENT HAS RESULTED IN A PROCEDURE DELAY. THERE WAS NO INJURY TO THE PATIENT.IT WAS FURTHER STATED THAT OVERHEATING AT THE TOP OF THE DRILL OCCURRED WITHIN THE FIRST MINUTE. THE HEAT THEN RADIATED TO THE MOTOR PORTION. TESTED THE DRILL AND CAN CONFIRM THAT THE TOP OF THE DRILL OVERHEATED IN LESS THAN A MINUTE. PROCEDURE WAS COMPLETED WITH BACKUP DEVICE. DEVICE BEING RUN AT 80,000 RPM. DEVICE BEING RUN AT FORWARD MOTION. IRRIGATION WAS BEING USED, 15-25CC/MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349028 ↗
• MalfunctionMay 7, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE VISAO DRILL WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257264 ↗
• MalfunctionApr 16, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA-OP, THE VISAO DRILL HANDPIECE WAS GETTING HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116508 ↗
• MalfunctionFeb 26, 2024Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT VISAO DRILL WAS OVERHEATING AND NOISY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775201 ↗
• MalfunctionFeb 16, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DEVICE GETS WARM AFTER 10 MINS OF USAGE, AND HAS A MISSING INNER RING. THE DEVICE COULD BE USED FOR COMPLETING THE PROCEDURE BUT WAS VERY WARM. IT WAS RUN AT 6000 K RPM, AT 30-40 ML/MIN. MODE USED WAS COOL AND RINSE MODE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18718320 ↗
• MalfunctionDec 19, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING INSTALLATION, VISAO DRILL WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361493 ↗
• MalfunctionNov 28, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DEVICE GETS WARM IN MORE THAN A MINUTE, DEVICE WAS IN USE FOR 10 MINS WHEN THE OVERHEATING OCCURRED. SPEED WAS 60, FLOWRATE WAS 30-40 ML/MIN. NO PATIENT IMPACT. IN ANALYSIS DEVICE WAS OVERHEATING IN 1 MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18214428 ↗
• MalfunctionNov 8, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE DEVICE OVERHEATED. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096764 ↗